Drug product
Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.
D-1422-2012
Product summary
- Event
- Event 51880
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,848 bottles
- Official record key
drug-enforcement:D-1422-2012
Official wording
Reason: Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Code information: Lot #: : PUB1040, Exp 08/2015
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling Illegible: Missing